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Randomised Controlled Trial of the effect of Advice On Sexual Intercourse after 36 weeks on pregnancy duration and the rate of induction of labour thereafter
ISRCTN ISRCTN82333699
DOI 10.1186/ISRCTN82333699
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised Controlled Trial of the effect of Advice On Sexual Intercourse after 36 weeks on pregnancy duration and the rate of induction of labour thereafter
Scientific title
Acronym RCTAOSI
Serial number at source N/A
Study hypothesis Current evidences suggest that sexual intercourse has a role in promoting labour. All mentioned evidences are based on prospective observational studies and it is unknown at present whether advice on sexual intercourse at 36 weeks would be of value in initiation of labour. Hence, we propose an interventional study: a randomised controlled trial to study the effect of advising or encouraging sexual intercourse after 36 weeks gestation to ascertain the effect of the intervention on the primary outcomes of:
1. Actual frequency of sexual activity
2. Duration of pregnancy
3. Requirement of induction of labour for prolonged pregnancy
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Medical Ethics Committee of University of Malaya Medical Centre on the 16th August 2006 (ref: 523.3).
Study design Single-centre, single-blind, randomised controlled trial.
Countries of recruitment Malaysia
Disease/condition/study domain Pregnancy
Participants - inclusion criteria Women attending University Malaya Medical Centre (UMMC) antenatal clinic at 35 weeks gestation will be approached to enter the study. Women who have not been sexually active in the last 6 weeks will be eligible for trial entry.
Participants - exclusion criteria 1. Placenta praevia
2. Antepartum haemorrhage
3. Ruptured membranes
4. Previous caesarean
5. Hypertension
6. Diabetes
7. Growth restricted baby
8. Multiple gestations
9. Previous stillbirth
10. Foetal anomalies
Anticipated start date 01/09/2007
Anticipated end date 01/09/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1623
Interventions Advice on sexual intercourse versus usual care only.
Primary outcome measure(s) 1. Duration of pregnancy
2. Rate of induction of labour
Secondary outcome measure(s) 1. Hospital admissions since randomisation
2. Length of gestation
3. Prelabour rupture of membranes (PROM)
4. Method of labour induction (if any)
5. Indication for labour induction
6. Length of labour
7. Epidural use in labour
8. Oxytocin augmentation
9. Mode of delivery
10. Indications for operative delivery
11. Endometritis
12. Maternal hospital stay
13. Apgar score
14. Cord pH at birth
15. Admission to the neonatal unit
16. Indication for neonatal admission
Sources of funding University of Malaya Medical Centre (Malaysia)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23145957
Contact name Dr  Nada  Sabir
  Address B1206 University Towers
No.28, Section 11
Petaling Jaya
  City/town Selangor
  Zip/Postcode 46200
  Country Malaysia
  Tel +60 (0)1 2359 3272
  Email nada_sabir@yahoo.co.uk
Sponsor University of Malaya Medical Centre (Malaysia)
  Address 50603
  City/town Kuala Lumpur
  Zip/Postcode 50603
  Country Malaysia
  Tel +60 (0)3 7949 2472
  Fax +60 (0)3 7959 1471
  Email sitizawiah@um.edu.my
  Sponsor website: http://www.um.edu.my
Date applied 19/08/2007
Last edited 15/03/2013
Date ISRCTN assigned 11/09/2007
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